Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008 Feb 7;358(6):568-579.
http://content.nejm.org/cgi/content/abstract/358/6/568
http://content.nejm.org/cgi/content/full/358/6/568
http://content.nejm.org/cgi/reprint/358/6/568.pdf
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N Engl J Med. 2008 Feb 7;358(6):568-79.
Comment in:
• N Engl J Med. 2008 Feb 7;358(6):637-9.
• N Engl J Med. 2008 Jun 5;358(23):2514-5; author reply 2515-6.
• N Engl J Med. 2008 Jun 5;358(23):2515; author reply 2515-6.
HLA-B*5701 screening for hypersensitivity to abacavir.
Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jägel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P, Nolan D, Hughes S, Hughes A, Ryan S, Fitch N, Thorborn D, Benbow A; PREDICT-1 Study Team.
Royal Perth Hospital and Murdoch University, Perth, Australia.
BACKGROUND: Hypersensitivity reaction to abacavir is strongly associated with the presence of the HLA-B*5701 allele. This study was designed to establish the effectiveness of prospective HLA-B*5701 screening to prevent the hypersensitivity reaction to abacavir. METHODS: This double-blind, prospective, randomized study involved 1956 patients from 19 countries, who were infected with human immunodeficiency virus type 1 and who had not previously received abacavir. We randomly assigned patients to undergo prospective HLA-B*5701 screening, with exclusion of HLA-B*5701-positive patients from abacavir treatment (prospective-screening group), or to undergo a standard-of-care approach of abacavir use without prospective HLA-B*5701 screening (control group). All patients who started abacavir were observed for 6 weeks. To immunologically confirm, and enhance the specificity of, the clinical diagnosis of hypersensitivity reaction to abacavir, we performed epicutaneous patch testing with the use of abacavir. RESULTS: The prevalence of HLA-B*5701 was 5.6% (109 of 1956 patients). Of the patients receiving abacavir, 72% were men, 84% were white, and 18% had not previously received antiretroviral therapy. Screening eliminated immunologically confirmed hypersensitivity reaction (0% in the prospective-screening group vs. 2.7% in the control group, P
Publication Types:
• Multicenter Study
• Randomized Controlled Trial
• Research Support, Non-U.S. Gov't
PMID: 18256392